Boston Scientific recalls ROTAWIRE Drive and wireClip Torquer devices due to pouch seals potentially compromising sterility. Affected units include specific batch numbers and model labels.
Pouch seals may be open, compromising sterility.
Boston Scientific is recalling certain ROTAWIRE Drive and wireClip Torquer devices because the pouch seals might be open, which could compromise sterility. This means the devices may not be sterile when used, posing a risk of infection during medical procedures.
The pouch seals on the devices may be open, which could allow contamination. This compromises the sterility of the devices, meaning they might not be safe for medical procedures.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices could face infection if the devices are not sterile.
Check for the product labels: ROTAWIRE Drive, wireClip Torquer, or ROTAWIRE Drive Extra Support. Look for batch numbers listed in the recall notice: 27630467, 27632712, and other specific numbers.
Look for the product name and batch numbers listed in the recall notice to confirm if your device is affected.
The pouch seals may be open, which could compromise sterility, meaning the devices might not be safe for medical procedures.
Check the device labels for the product name and batch numbers listed in the recall notice to see if it is affected.
Yes, specific batch numbers like 27630467, 27632712, and others listed in the recall notice are affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0916-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0916-2022 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
